Evidence map›Paper›PMID 42461386›Full record

ArticleBioprocess and biosystems engineering2026

Operationalizing digital twins in biomanufacturing through interoperable process analytical technology.

Abhijeet Satwekar, M Cyndell Gracieux-Singleton, Chris Cummings, Jonquil A R Horton, Monica Accerbi, Veerabhadraiah Palakollu, Ryan R Barton, Sandeep Kedia, Thomas Cornish, Katharina S Yandrofski and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioprocess and biosystems engineering, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Abhijeet SatwekarAnalytical Excellence & Program Management, Global Analytical Development, Global CMC Development, Merck Serono S.P.A. (A Business of Merck KGaA, Darmstadt, Germany), Via Luigi Einaudi 11, Guidonia Montecelio, 00012, , Rome, Italy. abhijeet.satwekar@merckgroup.com.
M Cyndell Gracieux-SingletonGolden LEAF Biomanufacturing Training and Education Center, North Carolina State University, 850 Oval Drive, Raleigh, NC, 27606, USA.
Chris CummingsGolden LEAF Biomanufacturing Training and Education Center, North Carolina State University, 850 Oval Drive, Raleigh, NC, 27606, USA.
Jonquil A R HortonGolden LEAF Biomanufacturing Training and Education Center, North Carolina State University, 850 Oval Drive, Raleigh, NC, 27606, USA.
Monica AccerbiTechnical Operations, National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE, 19713, USA.
Veerabhadraiah PalakolluTechnical Operations, National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE, 19713, USA.
Ryan R BartonGolden LEAF Biomanufacturing Training and Education Center, North Carolina State University, 850 Oval Drive, Raleigh, NC, 27606, USA.
Sandeep KediaNational Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE, 19713, USA.
Thomas CornishGlobal Technology, Engineering, & Launch, Pfizer Inc, 7000 Portage Rd, Kalamazoo, MI, 49001, USA.
Katharina S YandrofskiInstitute for Bioscience and Biotechnology Research, National Institute of Standards and Technology, 9600 Gudelsky Drive, Rockville, MD, 20850, USA.
Roger HartNational Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE, 19713, USA.
Dannielle BerlinghieriProject Management Office, National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE, 19713, USA.
James SaylorProject Management Office, National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE, 19713, USA.
Kelvin H LeeNational Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE, 19713, USA.

Funding

U.S. Department of Commerce, National Institute of Standards and Technology 70NANB17H002U.S. Department of Commerce, National Institute of Standards and Technology 70NANB21H086 (Subaward Number: UDR0000507)U.S. Department of Commerce, National Institute of Standards and Technology. 70NANB21H086 (Subaward Number: UDR0000507)
6 · The paper itself

Abstract

The integration of Process Analytical Technologies (PAT) within digital twin architecture represents an important advancement in biopharmaceutical manufacturing. While existing literature has separately addressed digital twin dimensions, interoperability levels, and manufacturing standards, their systematic integration for real-time bioprocess control remains underexplored. Our work provides an operational framework that bridges established frameworks on digital twin dimensions with hierarchical interoperability levels. Our conceptual framework establishes an interoperability "triangle" wherein Data and Connection dimensions function as the central hub linking Physical and Virtual entities with Services to enable model-based predictive control (MPC) through PAT integration. We exemplify the practical application of our proposed approach using a galactosylation adaptive control case study that spans purpose-driven systematic technology assessment to operational deployment at the testbed. Our study provides theoretical advancement in digital twin operationalization and a practical approach for implementing MPC-enabled PAT systems in highly regulated biopharmaceutical manufacturing, with potential for applicability across multiple critical quality attributes, unit operations, and manufacturing scales.

Indexed as

BiotechnologyManufacturing IndustryBiomanufacturingDigital twinsInteroperabilityModel-based predictive controlProcess analytical technologies

Identifiers

PMID42461386
PMCPMC13424265

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.